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A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis-A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial
Journal article   Open access   Peer reviewed

A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis-A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial

John E. Edwards, Michael M. Schwartz, Clint S. Schmidt, Jack D. Sobel, Paul Nyirjesy, Florian Schodel, Erica Marchus, Mary Lizakowski, Elizabeth A. DeMontigny, Jesse Hoeg, …
Clinical infectious diseases, v 66(12), pp 1928-1936
15 Jun 2018
DOI: https://doi.org/10.1093/cid/ciy185
PMID: 29697768
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://academic.oup.com/cid/article-pdf/66/12/1928/25084683/ciy185.pdfView
Published, Version of Record (VoR) Open
url
https://doi.org/10.1093/cid/ciy185View
Published, Version of Record (VoR) Open

Abstract

Immunology Infectious Diseases Life Sciences & Biomedicine Microbiology Science & Technology
Background. Recurrent vulvovaginal candidiasis (RVVC) is a problematic form of mucosal Candida infection, characterized by repeated episodes per year. Candida albicans is the most common cause of RVVC. Currently, there are no immunotherapeutic treatments for RVVC. Methods. This exploratory randomized, double-blind, placebo-controlled trial evaluated an immunotherapeutic vaccine (NDV-3A) containing a recombinant C. albicans adhesin/invasin protein for prevention of RVVC. Results. The study in 188 women with RVVC (n = 178 evaluable) showed that 1 intramuscular dose of NDV-3A was safe and generated rapid and robust B-and T-cell immune responses. Post hoc exploratory analyses revealed a statistically significant increase in the percentage of symptom-free patients at 12 months after vaccination (42% vaccinated vs 22% placebo; P = .03) and a doubling in median time to first symptomatic episode (210 days vaccinated vs 105 days placebo) for the subset of patients aged < 40 years (n = 137). The analysis of evaluable patients, which combined patients aged < 40 years (77%) and = 40 years (23%), trended toward a positive impact of NDV-3A versus placebo (P = .099). Conclusions. In this unprecedented study of the effectiveness of a fungal vaccine in humans, NDV-3A administered to women with RVVC was safe and highly immunogenic and reduced the frequency of symptomatic episodes of vulvovaginal candidiasis for up to 12 months in women aged < 40 years. These results support further development of NDV-3A vaccine and provide guidance for meaningful clinical endpoints for immunotherapeutic management of RVVC.

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156 citations in Web of Science
148 citations in Scopus

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UN Sustainable Development Goals (SDGs)

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#3 Good Health and Well-Being

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Collaboration types
Domestic collaboration
Web of Science research areas
Immunology
Infectious Diseases
Microbiology
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